The Recall Desk

Manufacturer

PENTAX of America Inc

33 recalls in our database name PENTAX of America Inc as the manufacturing or recalling firm.

What the numbers show

Total
33
Critical
0
Severe
0
Most recent
2025-08-27

Of the 33 recalls from PENTAX of America Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–33 of 33

  • HighFDA (Devices)·Z-2326-2017·2017-06-21

    Pentax Video Nasopharyngolaryngoscopes Recalled for Loose Suction Arms

    Pentax of America Inc is recalling 1,701 Video Nasopharyngolaryngoscopes due to loose suction arms. The action documents corrective measures taken in 2010-2011.

    Product
    Video Naso pharyngo Laryngoscopes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2325-2017·2017-06-21

    Pentax Video Cytoscopes Recalled for Loose Suction Arms

    Pentax of America Inc. is recalling Video Cytoscopes to correct loose suction arms. This action retrospectively documents corrections made in 2010-2011.

    Product
    Video Cytoscopes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2324-2017·2017-06-21

    Pentax Video Bronchoscopes Recalled for Loose Suction Arms

    Pentax of America Inc is recalling 1,701 video bronchoscopes due to loose suction arms. The action retrospectively documents corrections made in 2010-2011.

    Product
    Video Bronchoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1075-2017·2017-02-01

    Pentax Rigid Laryngostroboscopes Field Correction for Instructions for Use

    Pentax of America is revising the Instructions for Use for Rigid Laryngostroboscopes Models 9106 and 9108.

    Product
    Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0757-2017·2016-12-21

    Pentax Ultrasound Video Bronchoscope Recalled for Incorrect Instructions

    Pentax of America Inc. is recalling 113 Ultrasound Video Bronchoscopes because they shipped with outdated instructions for use.

    Product
    Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal Passage
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0636-2017·2016-11-30

    Pentax Video Colonoscope Recall for Missing Operation and Reprocessing Instructions

    Pentax of America is recalling video colonoscopes shipped between April 2014 and September 2015 because they included outdated instruction manuals and lacked required reprocessing adaptors.

    Product
    Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0318-2017·2016-11-02

    Pentax Video Gastroscope Recall for Updated Operation and Reprocessing Instructions

    Pentax of America Inc is recalling video gastroscopes to provide customers with the most recent Operation and Reprocessing Instructions (IFUs).

    Product
    Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2875-2016·2016-09-28

    Pentax Video Bronchoscopes Recalled for Incorrect Operation and Reprocessing Instructions

    Pentax of America Inc. is recalling 1,719 video bronchoscopes because they contain an incorrect Operation and Reprocessing IFUS.

    Product
    Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Pentax

company

Country
Japan
Founded
1919
Parent company
Ricoh

Official website

Source: Wikidata (Q503673), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.